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Clinical Trial to Test Safety of MRSA Drug Candidate

MRSA bacteria (CDC)

Scanning electron micrograph image of MRSA bacteria (Janice Haney Carr, Centers for Disease Control and Prevention)

Enanta Pharmaceuticals, a biotechnology company in Watertown, Massachusetts, is starting an early-stage clinical trial of an antibiotic to treat methicillin-resistant Staphylococcus aureus or MRSA infections. The drug, code-named EDP-788, is being developed under a contract with National Institute of Allergy and Infectious Diseases, part of National Institutes of Health.

MRSA is a bacteria resistant to many current antibiotics that cause skin infections, but can become life-threatening surgical site, blood stream, or pneumonia infections, especially in health care facilities. Health care-associated MRSA infections often occur with invasive procedures requiring intravenous tubing, surgeries, dialysis, or artificial joints.

Pew Health Initiatives says MRSA infections result in 368,000 hospitalizations leading to 19,000 deaths a year in the U.S., with annual costs estimated between $3.2 to $4.2 billion. Data from Centers for Disease Control and Preventions indicate MRSA blood stream infections are declining, with the number of hospitalized patients dropping nearly 50 percent between 1997 and 2007.

Enanta’s EDP-788 is from a new class of antibiotics known as bicyclolides, engineered compounds that the company says bind in a unique way to the genes of the target bacteria. This unique binding capability makes bicyclolides potential candidates to treat drug resistant bacteria, including MRSA and vancomycin resistant enterococci.

In 2011, National Institute of Allergy and Infectious Diseases awarded Enanta a contract to develop medical countermeasures to drug-resistant bacteria, with $23.5 million awarded to the company by September 2013 for preclinical studies and early-stage clinical trials. If all options are exercised by the agency, the contract could pay Enanta as much as $42.7 million.

In a September 2013 company statement, Enanta CEO Jay Luly said bicyclolides show promising activity in lab tests against isolates resistant to vancomycin, linezolid, and daptomycin, three leading therapies against drug-resistant bacteria.

EDP-788 is being configured as a precursor agent that remains inactive until converted by the body into an active compound. In the clinical trial, an oral form of the drug will be tested against a placebo for safety and chemical activity in the body with 64 healthy volunteers. The company says an intravenous form of the drug is also being developed.

Drug-resistant bacteria are a newer product line for Enanta. The company’s lead compounds are designed to inhibit genetic replication of hepatitis C viruses.

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